Low-dose Hormone Therapy for Relief of Vasomotor Symptoms

April 16, 2015 updated by: Bayer

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Determine the Lowest Effective Dose of Combinations of Oral Drospirenone and 17 Beta-Estradiol for the Relief of Moderate to Severe Vasomotor Symptoms in Postmenopausal Women Over a Treatment Period of 12 Weeks

The purpose of this study is to determine the lowest effective dose of the study drug for the relief of moderate to severe vasomotor symptoms in postmenopausal women for 12 weeks.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.

Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
735

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Chandler, Arizona, United States, 85225
      • Phoenix, Arizona, United States, 85031
      • Tucson, Arizona, United States, 85712
      • Tucson, Arizona, United States, 85741
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Paramount, California, United States, 90723
      • San Diego, California, United States, 92103
      • San Diego, California, United States, 92108
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92121
      • Valley Village, California, United States, 91607
      • Vista, California, United States, 92083
    • Colorado
      • Colorado Springs, Colorado, United States, 80910
      • Denver, Colorado, United States, 80218
    • Connecticut
      • New Britain, Connecticut, United States, 06050
    • Florida
      • Boynton Beach, Florida, United States, 33437
      • Clearwater, Florida, United States, 33761
      • Daytona Beach, Florida, United States, 32114
      • Fort Myers, Florida, United States, 33916
      • Jacksonville, Florida, United States, 32216
      • Lake Worth, Florida, United States, 33461
      • Leesburg, Florida, United States, 34748
      • Miami, Florida, United States, 33186
      • Miami, Florida, United States, 33169
      • New Port Richey, Florida, United States, 34655
      • Tampa, Florida, United States, 33607
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Atlanta, Georgia, United States, 30328
      • Decatur, Georgia, United States, 30034
    • Idaho
      • Boise, Idaho, United States, 83702
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Arlington Heights, Illinois, United States, 60004
      • Champaign, Illinois, United States, 61820
      • La Grange Park, Illinois, United States, 60526
    • Indiana
      • Newburgh, Indiana, United States, 47630
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Louisiana
      • Amite, Louisiana, United States, 70422
      • Marrero, Louisiana, United States, 70072
    • Michigan
      • Paw Paw, Michigan, United States, 49079
    • Minnesota
      • Chaska, Minnesota, United States, 55318
    • Missouri
      • Springfield, Missouri, United States, 65802
    • Montana
      • Billings, Montana, United States, 59101
      • Billings, Montana, United States, 59102
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
    • Nevada
      • Las Vegas, Nevada, United States, 89104
      • Reno, Nevada, United States, 89502
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
      • New Brunswick, New Jersey, United States, 08901
      • Princeton, New Jersey, United States, 08540
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
      • Winston-Salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58105
    • Ohio
      • Cleveland, Ohio, United States, 44122
      • Columbus, Ohio, United States, 43213
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
      • Tulsa, Oklahoma, United States, 74105
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16502
      • Philadelphia, Pennsylvania, United States, 19114
      • Pittsburgh, Pennsylvania, United States, 15206
      • Wexford, Pennsylvania, United States, 15090
    • South Carolina
      • Columbia, South Carolina, United States, 29201
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Chattanooga, Tennessee, United States, 37403
      • Memphis, Tennessee, United States, 38120
    • Texas
      • Dallas, Texas, United States, 75234
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77004
    • Vermont
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Norfolk, Virginia, United States, 23507
      • Richmond, Virginia, United States, 23294
    • Washington
      • Renton, Washington, United States, 98055
      • Seattle, Washington, United States, 98105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- Postmenopausal women >40 years of age experiencing a minimum of 7 to 8 moderate to severe hot flushes per day or 50 to 60 moderate to severe hot flushes per week

Exclusion Criteria:

  • The usual exclusion criteria for hormone therapy apply
  • Intake of medications other than hormones affecting hot flushes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 0.5mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
Drug: 0.5mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
Experimental: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
Drug: 0.25mg DRSP / 0.5mg E2 (BAY86-4891)
One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
Experimental: Estradiol (E2 0.3mg)
One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
Drug: Estradiol (E2 0.3mg)
One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
Placebo Comparator: Placebo
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
Drug: Placebo
Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
Time Frame: Baseline until 12 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.
Baseline until 12 weeks of treatment
Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Median Value)
Time Frame: Baseline until 4 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.
Baseline until 4 weeks of treatment
Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)
Time Frame: Baseline until 12 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity of moderate to severe hot flushes minus baseline severity.
Baseline until 12 weeks of treatment
Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Median Value)
Time Frame: Baseline until 4 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity of moderate to severe hot flushes minus baseline severity.
Baseline until 4 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in Vaginal pH
Time Frame: Baseline until 12 weeks of treatment
Vaginal pH determined following speculum examination using vaginal pH paper and recorded on case report form (CRF). Absolute change calculated as week 12 pH minus baseline pH.
Baseline until 12 weeks of treatment
Change From Baseline to Week 12 in Vaginal Maturation Value
Time Frame: Baseline until 12 weeks of treatment
Calculated as (percentage of superficial cells) + 0.5 * (percentage of intermediate cells). Absolute change calculated as week 12 value minus baseline value.
Baseline until 12 weeks of treatment
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Dryness'
Time Frame: After 12 weeks of treatment
Subjects self-assessed symptom severity
After 12 weeks of treatment
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal and/or Vulvar Irritation/Itching'
Time Frame: After 12 weeks of treatment
Subjects self-assessed symptom severity
After 12 weeks of treatment
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Dysuria'
Time Frame: After 12 weeks of treatment
Subjects self-assessed symptom severity
After 12 weeks of treatment
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Pain Associated With Sexual Activity'
Time Frame: After 12 weeks of treatment
Subjects self-assessed symptom severity
After 12 weeks of treatment
Symptoms of Vulvar and Vaginal Atrophy: Severity of Symptom 'Vaginal Bleeding Associated With Sexual Activity'
Time Frame: After 12 weeks of treatment
Subjects self-assessed symptom severity
After 12 weeks of treatment
Urogenital Symptoms: Number of Participants With Symptom 'Frequent Urination'
Time Frame: After 12 weeks of treatment
Subjects self-assessed presence or absence of symptom
After 12 weeks of treatment
Urogenital Symptoms: Number of Participants With Symptom 'Involuntary Urination When Laughing or Coughing'
Time Frame: After 12 weeks of treatment
Subjects self-assessed presence or absence of symptom
After 12 weeks of treatment
Urogenital Symptoms: Number of Participants With Symptom 'Urination at Night'
Time Frame: After 12 weeks of treatment
Subjects self-assessed presence or absence of symptom; and if present recorded average number of times per night: 1; 2 to 4; more than 4.
After 12 weeks of treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)
Time Frame: Baseline until 12 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 12 number of moderate to severe hot flushes minus baseline number.
Baseline until 12 weeks of treatment
Change From Baseline to Week 4 in Weekly Frequency of Moderate to Severe Hot Flushes (Mean Value)
Time Frame: Baseline until 4 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Absolute change calculated as week 4 number of moderate to severe hot flushes minus baseline number.
Baseline until 4 weeks of treatment
Change From Baseline to Week 12 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)
Time Frame: Baseline until 12 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 12 severity moderate to severe hot flushes minus baseline severity.
Baseline until 12 weeks of treatment
Change From Baseline to Week 4 in Weekly Mean Daily Severity of Moderate to Severe Hot Flushes (Mean Value)
Time Frame: Baseline until 4 weeks of treatment
Subjects record daily on the diary cards the frequency and severity of hot flushes during the treatment period as none, mild, moderate or severe. Daily score is calculated as [(2 x number of moderate hot flushes) + (3 x number of severe hot flushes)] / (total number of moderate to severe hot flushes on that day). Range = 0 (lowest severity) to 3 (highest severity). Absolute change calculated as week 4 severity moderate to severe hot flushes minus baseline severity.
Baseline until 4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 91493
  • 310184 (Other Identifier: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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